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Mar 23, 2017

FDA Guidance Answers Questions Regarding Data Integrity

FDA is seeing too many data integrity-related violations. 


by David Jensen


Marketing Communications


MasterControl


An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “Data Integrity and Compliance with cGMP.” The purpose of the guidance is to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.


FDA finds the increase of data integrity violations troubling. Nevertheless, the agency’s current position on the content of the guidance is that it should be viewed only as recommendations. The use of the word “should” in Agency guidances means that something is suggested, but not required.

Mar 21, 2017

The Most Important Four-Letter Words in ISO 9001:2015


If transitioning to the new ISO 9001: 2015,
be very familiar with both four-letter words
emphasized in the document: risk and plan.

by Christine Park


Christine Park & Associates


Most organizations are well under way with the transition to the new ISO 9001:2015.  As such you should be very familiar with the emphasis on two four-letter words found throughout the document …. risk and plan. While these words are emphasized throughout the document, they aren’t new within the business or quality management systems.

Risk-based thinking is something we all do every day and has always been important in business management.  Now that the new ISO standard requires the quality management system to be aligned with business strategy, the use of risk management allows for greater flexibility and less prescription.  Additionally, the use of risk is considered a preventive tool and since it has been integrated throughout the standard, the specific clause for preventive action was eliminated from the standard.

Mar 16, 2017

FDA Eager to be Innovative Partner with Expedited Access Pathway

Expedited Access Pathway: for patients
who have few or no other options.


by David Jensen

Marketing Communications

 
MasterControl



Part of FDA’s prime directive is to assure the safety, effectiveness and quality of biological products and medical devices. So the notion of FDA endorsing the acceleration of product development might raise some eyebrows. However, FDA officials and industry experts alike seem to agree that with some patients waiting is not the hardest part, it’s actually not an option.

Two accelerated manufacturing programs currently in the spotlight are the 21st Century Cures Act and its medical device sibling, the Expedited Access Pathway (EAP) program. Dissenters believe these programs might compel FDA to relax its regulatory oversight in order to fast-track a product’s development and manufacturing. According to Center for Devices and Radiological Health (CDRH) director Jeffrey Shuren, it’s quite the opposite. In an FDA Voice blog post, Shuren summed up EAP as a way to “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.”

Mar 14, 2017

The Inner Game of Continuous Improvement

Overcoming anxiety and self-doubt can
help you win in sport and in your career.

by Jon Miller


Co-founder and Partner

Gemba Academy


Five-time Superbowl winner Tom Brady credits reading The Inner Game of Tennis by Tim Gallwey for helping him overcome anxiety and self-doubt, and to keep winning. I read the book looking for parallels and general lessons that could be applied to workplace performance and continuous improvement, and was not disappointed. Here is a summary of what I learned about what I will call “the inner game of continuous improvement.”

Mar 9, 2017

Brave New World: The Mutual Recognition of CGMP Inspections


The United States and the European Union
 have agreed to to recognize inspection
 of each other's drug manufacturing facilities.

by Mark I. Schwartz 

Director

Hyman, Phelps & McNamara PC


Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see here and here) amends the Pharmaceutical Annex to the 1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and saving millions of dollars in repetitive inspections.

FDA has stated that they believe this “…initiative will result in greater efficiencies for both regulatory systems and provide a more practical means to oversee the large number of drug manufacturing facilities outside of the U.S. and EU.”

Mar 7, 2017

The Data Driven Reality of Clinical Trials

Metrics provide the foundation for 
business intelligence for clinical trials, 
measuring success or failure. 


by Craig Morgan

Head of Marketing

goBalto


Why are metrics important in starting clinical trials? This question may seem counter intuitive, as we are exposed almost daily to the dire performance of clinical trials and their spiraling costs resulting from incurred delays.

According to a recent study by KPMG (1), within the pharmaceutical industry, the return on R&D expenditure has fallen from an industry average of approximately 20 percent 20 years ago, to 10 percent now, with the average cost of developing a drug rising during that period at a rate 7.4 percent higher than inflation, with the increasing costs of conducting clinical trials responsible for most of this increase (2). It is estimated that it now costs upwards of $2 billion dollars to bring a new drug to market (3).

Mar 2, 2017

2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

MDSAP reduces regulatory burden on
medical devices while demonstrating
compliance at the same time.


by Marci Crane

Marketing Communications Specialist


For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that will satisfy the requirements of multiple regulatory jurisdictions.”(2)

Mar 1, 2017

Supplier Approval Challenges Under FSMA



The Food Safety Modernization Act (FSMA)
is posing many challenges for food manufacturers
and those who supply ingredients to them.


by Erika Miller

Food Safety Specialist

D.L. Newslow & Associates, Inc.



As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Programs, or FSVPs, will soon add another layer as some compliance dates start as soon as May 30, 2017. The largest corporations have the earliest compliance dates, and although these organizations may have deep pockets they also have many facilities - which can present a major implementation challenge.